Clinical Trial

A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.
Protocol Amendment History 2 changes
minor Trial arms changed: 8 -> 9 2026-07-28
notable Trial sites expanded: 6 -> 14 locations 2026-07-28
Trial Details
NCT Number NCT07141706
Lead Sponsor DualityBio Inc.
Conditions Advanced/Metastatic Solid Tumors
Enrollment 253 participants
Start Date 2025-09-23
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-27